Impact of case manager intervention on psychotic episode recurrence in young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how case managers trained in early psychosis care can reduce the recurrence of psychotic episodes in patients aged 16 to 30 who have experienced their first episode. The intervention focuses on personalized support, psycho-education, family involvement, and socio-professional reintegration over a three-year follow-up period. By implementing structured case management, the study aims to improve the overall care paradigm for young individuals facing early psychosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The patient or their close relative must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is available for a 3-year follow-up.
* Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by:

  * Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ;
  * Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry);
  * A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features.
* Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service.
* At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission.

Exclusion Criteria:

* The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
* The subject, or one of the parents for minor patients, refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patients has an IQ less than or equal to 55
* The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition
* The patient is pregnant or breastfeeding

Where it's running

• CHU de Montpellier
  Montpellier, France Recruiting
• CHU de Nîmes
  Nîmes, France Recruiting
• Centre Hospitalier Léon-Jean Grégory
  Thuir, France Recruiting
• CHU de TOULOUSE
  Toulouse, Choisir Une Région, France Not yet recruiting
• CH Saint Marie Clermont-Ferrand
  Clermont-Ferrand, France Not yet recruiting
• CHU Nice
  Nice, France Not yet recruiting

Study contacts

• Principal investigator: Aurélie Schandrin — CHU Nimes
• Study coordinator: Aurélie Schandrin
• Email: aurelie.schandrin@chu-nimes.fr
• Phone: 04.66.68.34.26

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.